Kornimate/medical-research-clean huggingface dataset:
assessment of the efficacy of a neoadjuvant combination: "chemotherapy-targeted therapy" in breast cancer.

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "taxotere-erbitux".


Eligibility criteria:
inclusion criteria: * § age \> or equal to 18 years.§ * performance status inferior or equal to 1 (who criteria) * histologically proven breast cancer, non metastatic, with clinical tumor diameter \> or equal to 2 cm. * hr negative and her 2 negative. * clinical stage ii and iiia. * non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§ * adequate hematological, renal and hepatic functions : neutrophils \> 2.109 /l, platelets \> 100.109 /l, hb \> 10 g/dl, normal bilirubin, asat and alat inferior or equal to 2,5 uln (upper normal limit), alkaline phosphatases £ 2,5 uln, creatinine \ 60 ml/min.§ * written informed consent§ * affiliation with social security system (or profit being of such a mode) according to terms' of the law of august 9, 2004. exclusion criteria: * male patient. * pregnant or lactating women or childbearing potential with no efficacy contraception. * other breast cancer form and particularly inflammatory form and/or negliged (t4b or t4d).§ * non measurable tumor. * prior surgery or primary axillary dissection. * prior treatment for this new breast cancer. * under guardianship patient * patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured. * patient with an associated pathology considered incompatible with the study.§ cardiac, renal, medullar, respiratory or hepatic insufficiency. * significant neurological or psychiatric troubles.§ symptomatic or evolutive troubles in cns or metastasis. * peripheral neuropathy \> grade 2 nci-ctc (version 3.0) * previous allergy with polysorbate 80. * concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy. * patients non stable for the following 6 months or leaving at a great distance of the participating center.

Keywords: breast cancer. triple negative. neoadjuvant chemotherapy. targeted therapy.
bacterial biofilms in reconstructive breast prostheses following mastectomy

Conditions: Breast Implant Infection; Mammoplasty

Summary: breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (cc), and/or breast-implant associated anaplastic large cell lymphoma (bia-alcl). the research team, which has already extensively characterized bacterial pathogenesis in the urinary tract and designed non-antibiotic therapeutics to reduce the incidence of catheter-associated urinary tract infections (cautis), and proposal will study bacteria-breast implant interactions and explore further the impact of the breast microbiome. the proposed research provides a greater understanding of which bacteria can colonize breast implants, their source, and how effective antibiotic pocket irrigation is at eliminating them, and begins to examine the mechanisms by which bacteria bind and colonize the implant surface. these insights will set the groundwork for developing new therapeutic agents that can disrupt the binding of certain bacteria to breast implants. strategies that minimize problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant complications, limit antibiotic-related side effects, and reduce bacterial resistance.


Eligibility criteria:
inclusion criteria: * female * between 18 and 75 years of age, inclusive * undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants * able to understand and willing to sign an irb-approved written informed consent document exclusion criteria: * male
epidural and dorsal root stimulation in humans with spinal cord injury

Conditions: Spinal Cord Injuries; Paraplegia; Tetraplegia; Paralysis

Summary: a study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.

this study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after sci, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with sci.

Eligibility criteria:
inclusion criteria: * spinal cord injury due to trauma located at or above the tenth thoracic vertebrae * american spinal injury association grading scale of a, b, c, or d * intact spinal reflexes below the level of sci * sci must have occurred at least 1 year prior to study enrollment * at least 22 years of age * if female, must be willing to use medically-acceptable method of contraception during study participation exclusion criteria: * currently a prison inmate, or awaiting trial, related to criminal activity * pregnancy at the time of screening for trial enrollment * active, untreated urinary tract infection * unhealed decubitus ulcer * unhealed skeletal fracture * spinal abnormality that may impede percutaneous implantation of spinal electrodes * untreated clinical diagnosis of psychiatric disorder * joint contractures that impede typical range of motion * non-mri-compatible implanted medical devices * other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.) * undergoing, or planning to undergo, diathermy treatment * active participation in an interventional clinical trial * history of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping * history of frequent and/or severe autonomic dysreflexia * history of seizure disorder * any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study
the outcomes of keystone perforator island flap versus lay open in re-recurrent pilonidal sinus disease

Conditions: Pilonidal Sinus Treatment

Summary: pilonidal disease is a common and annoying problem with a fair recurrence rate. every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.


Eligibility criteria:
inclusion criteria: * re-recurrent pilonidal disease exclusion criteria: * patients with proved anal or perineal malignancy or autoimmune disease * patient with pilonidal disease for the first time or for the first time of recurrence
pawsitive impacts of therapy dog visits

Conditions: Pain; Pain, Acute; Pain, Chronic; Pain, Intractable

Summary: the goal of this unique 18 month study is to better understand the experiences of pain patients in the royal university hospital (ruh) emergency department (ed), to create excellence in health care. the purpose is to measure the impact of visiting therapy dogs on reducing ed patient pain.

the goal of this unique 18 month study is to better understand the experiences of pain patients in the royal university hospital (ruh) emergency department (ed), to create excellence in health care. the purpose is to measure the impact of visiting therapy dogs on reducing ed patient pain. the background rationale is that pain is the primary reason individuals attend an ed, patient pain is generally not well managed in eds, saskatchewan eds have among the longest wait times in the country, and anxiety associated with ed waiting can negatively impact patients' pain. research suggests a therapy dog can change patients' perceptions of pain and its intensity and facilitate relaxation. the intervention will be examined for its impact on patients' sensory pain (i.e., physical pain severity), affective pain (i.e., emotional pain unpleasantness) and anxiety. it is important to find creative, low-cost ways to respond to patients attending the ed for pain. the primary objective of this study is to generate new health-related knowledge on the ed pain patient experience. the secondary objectives are to implement effective end-of-grant knowledge translation and dissemination strategies and undertake a successful model of collaborative, multidisciplinary research among researchers, patient advisors and system representatives, rooted in a one health framework.

Eligibility criteria:
inclusion criteria: * over the age of 18 * able to provide consent * attending the emergency department because of pain/discomfort * canadian triage and acuity score (ctas) of 2-5 * willing to visit with a therapy dog team (intervention group only) exclusion criteria: * pain medications (specifically immediate release acetaminophen and opioid analgesics) within an hour prior to the visit

Keywords: pain emergency department therapy dog
comparison of two schemes of cryosurgery and imiquimod combination treatment for basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: to compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)

comparison of efficacy * number of patients: n=40 * arms: two equal arms (20 patients each) * inclusion criteria: basal cell carcinoma of the skin proven with biopsy * exclusion criteria: (1) size of the tumors \>5cm; (2) distance from the eyelid \ 5 * interim analysis: when at least 10 patients are included in each arm or at the end of the first year of the study the patients will be randomized in 2 groups group 1 (immunocryosurgery) and group 2 (cryoimmunotherapy) treatment protocols: group 1 (immunocryosurgery): patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. on day 14 a session of mild cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. group 2 (cryoimmunotherapy): patients will be submitted into cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) and subsequently will apply imiquimod on the tumor and a rim of 2mm around the tumor for 5 weeks in total. they will be evaluated in week 2 and 5. patients from both groups will be evaluated at 1, 3, 6, 12 months after termination of imiquimod treatment. in case of clinical relapse, it will be confirmed by biopsy and all the patients will treated with immunocrysurgery.

Eligibility criteria:
inclusion criteria: * biopsy proven basal cell carcinoma of the skin * size \<5cm * number of tumors \<5 cm * distance from eyelids, mouth 0,5cm exclusion criteria: * size \>5cm * number of tumors \> or =5 * distance from eyelids or mouth \< or =0.5cm

Keywords: basal cell carcinoma cryosurgery imiquimod immunocryosurgery
study of an orthotic designed to equalize leg lengths for patients with injuries managed in walking boots

Conditions: Joint Pain; Trouble Balancing

Summary: patients who undergo foot and ankle surgery are often made weight-bearing as tolerated (wbat) in a controlled ankle movement (cam) boot during their recovery and rehabilitation process. however, some patients may experience pain and discomfort while wearing the cam boot. a possible cause for this pain is that the boot elevates the injured foot higher than the other foot in the normal shoe. this uneven walking plane can lead to an abnormal gait or walking pattern, and may potentially lead to pain. our goal is the investigate if using a leg-length-evening orthotic can improve balance and/or decrease the development of pain in the legs and spine for patients who are wbat in a cam boot.

patients with foot and ankle injuries are often made weight-bearing as tolerated (wbat) in a controlled ankle movement (cam) boot at some point during their recovery and rehabilitation period. while wbat in a cam boot, patients often experience an asymmetric gait associated with the effective leg length discrepancy between the booted extremity (longer) and the contralateral extremity with a regular shoe (shorter). this asymmetry may cause balance problems or place strain on the patient's joints resulting in back, knee, and hip pain. an orthotic has been designed that is added to the outside of a regular shoe in order to eliminate the effective leg length discrepancy between the booted extremity and the contralateral limb. although this specific orthotic has not been studied, some proof of concept lies in studies that show that back pain can be managed with foot orthotics. the purpose of this study is to determine if using the leg-length-evening orthotic can improve balance and/or decrease the development of pain in the lower extremities and spine for patients who are wbat in a cam boot.

Eligibility criteria:
inclusion criteria: * must be weight bearing as tolerated and treated for at least 2 weeks in a controlled ankle movement boot. exclusion criteria: * unwilling to participate * being treated for an achilles tendon rupture (and therefore being treated in a controlled ankle boot with heel lifts) * member of a special population
effects of diabetes medications on adrenal function and intestinal microbiota

Conditions: Type 2 Diabetes

Summary: the primary aim of this observational study is to describe the effects of glucagon-like peptide-1 (glp-1) receptor agonists and sodium-glucose co-transporter 2 inhibitors ( sglt-2 inhibitors) on adrenal function. secondary endpoint is change in intestinal microbiota.

this is an observational study conducted in patients with type 2 diabetes starting treatment with either glp-1 receptor agonist or sodium-glucose cotransporter-2 (sglt-2) inhibitor. planned study cohort consists of 60 patients: 30 patients starting glp-1 receptor agonist treatment and 30 patients starting sglt-2 inhibitor treatment. all patients must have metformin as background therapy. all other diabetes medications are allowed. patients are tested before starting treatment, at 1 month (stool sample only), 3 months and 12 months after starting treatment. the primary endpoint is change in overnight urinary aldosterone corrected for creatinine. secondary endpoint is change in intestinal microbiota composition.

Eligibility criteria:
inclusion criteria: * age \> 18 years * type 2 diabetes * hba1c \< 10% * bmi \>32 * daily dose of metformin 1,5 g or more. * no change in diabetes treatment at least 90 days before starting the study. * never used sglt-2 inhibitors or/and glp-1 receptor agonist. * tested negative to glutamic acid decarboxylase 65 autoantibodies. exclusion criteria: * pregnancy and lactation. * use of systemic antibiotic treatment \< 60 days before starting the study. * use of spironolactone \< 60 days before starting the study. * use of oral contraceptives or hormonal replacement therapy. * use of immunosuppressive drug * heart failure new york heart association iii-iv * severe liver disease. * malignant disease.

Keywords: glp-1 receptor agonist sglt-2 inhibitor
bedside vs. standard microbiological blood culture diagnostics - bemidia study

Conditions: Sepsis Septic Shock

Summary: with a completely bedside blood culture diagnostics system (bactec blood culture system in combination with the accelerate id/ast system) it is possible to optimize the initial antimicrobial therapy in patients with sepsis and septic shock. prospective observational, open-label mono-center study to compare a completely bedside blood culture diagnostics system (bactec blood culture system in combination with the accelerate id/ast system and curetis univero system) with standard blood culture diagnostics in patients with sepsis or septic shock.


Eligibility criteria:
inclusion criteria: * patients with a new diagnosed sepsis or septic shock: emergency department, operating theatre, intensive care unit and planed blood culture diagnostics. * informed written consent exclusion criteria: * pediatric patients (\< 18 years) * dnr-order

Keywords: sepsis septic shock blood cultures anti-infective therapy
teleconsultations hypnosis sessions for patients with peripheral chronic neuropathic pain

Conditions: Peripheral Neuropathy; Pain

Summary: the aim of this study is to assess the feasibility of hypnosis sessions performed in teleconsultations and led by a nurse, for patients with peripheral chronic neuropathic pain. acceptability, satisfaction and effects (on pain and psychological distress) are also evaluated, comparing patients who have benefited from teleconsultations and those who did not.

factors explaining peripheral chronic neuropathic pains are complex ; they require a personalized therapeutic strategy and multidisciplinary management. among the recommended management, psychocorporal approaches such as hypnosis, are subject of recent interest. at the chu de bordeaux, the management of patients suffering from such chronic pains, consists of 5 hypnosis sessions, conducted face-to-face, each performed one month apart : the first session is carried out by a doctor and a hypnotherapist nurse and the 4 following sessions by the hypnotherapist nurse alone. however, it seems that this usual management is not easily accessible for patients who are geographically distant and/or who are unable to move due to excessive pain. in such situations, teleconsultations would avoid travel for these patients with low mobility and then would an interesting alternative to face-to-face consultations. few studies have been done on hypnosis sessions led by teleconsultations. so, the whole purpose of this study is to compare the management of 15 patients by teleconsultations (experimental arm) with 15 other patients seen in face-to-face (control arm) to evaluate feasibility of teleconsultation in hypnosis.

Eligibility criteria:
inclusion criteria: * patient aged over 18 years old, * patient suffering of from peripheral neuropathic pain for more than 1 year, * patient referred for hypnosis management as part of a coordinated care support, * patient who accepts teleconsultation, having the appropriate equipment to attend teleconsultations (computer, microphone, camera and stable internet connection with sufficient internet speed) and the ability to use it independently, * patient having signed a free, informed and written consent, * patient affiliated or beneficiary of the social security system. exclusion criteria: * patient with severe and unstable neurocognitive or psychiatric conditions (depression, psychoses, major cognitive impairments), * patient with uncorrected deafness, * patient with poor understanding of french * patient placed under judicial safeguard, guardianship or curatorship.

Keywords: peripheral chronic neuropathic pain hypnosis teleconsultations feasability
human amniotic mesenchymal cell secretome for neurodegeneration and neuroinflammation

Conditions: Amyotrophic Lateral Sclerosis; Multiple Sclerosis

Summary: neurodegenerative diseases are debilitating conditions characterized by chronic inflammation, leading to dysfunction of both the non-neuronal cellular components of the central nervous system and peripheral blood immune cells. thus, it is crucial to develop an innovative therapeutic strategy that not only effectively contrast neurodegeneration but also aims to reduce inflammation. the overall aim of the study is to provide a preclinical in vitro demonstration of the immunomodulatory and pro-regenerative potential of the human amniotic mesenchymal stromal cell (hamsc) secretome in counteracting neurodegeneration. this potential will be evaluated in three-dimensional in vitro models of neurodegenerative diseases, such as amyotrophic lateral sclerosis (als) and chronic demyelinating disease (multiple sclerosis - ms). to this end, the study includes sample collection from patients without pharmacological treatment and without medical devices. patients diagnosed with als, patients diagnosed with ms, and healthy volunteers will be recruited to collect blood samples and skin biopsies. patient-specific and control organoid platforms, mimicking cellular heterogeneity and tridimensional interactions within the central nervous system including the inflammatory compartment, will be developed to be used as a valuable tool to investigate the in vitro efficacy of the hamsc secretome.


Eligibility criteria:
inclusion criteria: * for patients with amyotrophic lateral sclerosis (als): aged between 50 and 60 years and similar age of onset and duration of the disease. * for patients with multiple sclerosis (ms): with recently confirmed diagnosis of ms, aged between 20 and 50 years and considering the male-to-female ratio in ms of approximately 2:1. * for healthy volunteers: spouses of patients unaffected by any neurological disease and matching their age and gender ratio for both conditions. exclusion criteria: * patients who do not consent to participate in the study. * ms patients who have received treatment with immunomodulators or corticosteroids and are in an acute phase of the disease.
remote ischemic preconditioning on the prognosis of patients with elective pci using drug-coated balloon

Conditions: Coronary Artery Disease

Summary: drug-coated balloon is being used more and more widely for the advantage of intervention without implantation. but the balloon needs to be released long enough to be effective. prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient. ripc can enhance patients' tolerance to ischemic events, so we believe that ripc application before the use of drug balloon for pci can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.

some patients receiving pci cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.ripc was found to improve tolerance to myocardial ischemia in patients. at the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.therefore, this study designed a parallel control group. the experimental group was treated with ripc before pci, while the control group was not treated before pci. the operator does not know whether the patient has undergone ripc or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.angiography was performed at 6 months, and qca was used to determine late lumen loss at 1 year.the 1-year incidence of target lesion failure events was assessed.

Eligibility criteria:
inclusion criteria: * diameter stenosis\>=50% by visual estimation intend to undergo drug-coated balloon implantation * target vessel diameter\> 2.5mm exclusion criteria: * chronic total obstructive lesion * diagnose patients with acute myocardial infarction \<24 hours * can't tolerate or not suitable for ripc * severe hepatic and renal insufficiency * expected survival \<1 year * severe calcification needing rotational atherectomy * intolerable to dual antiplatelet therapy